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Product
Development Engineer, 04043
Resides in Wisconsin
Salary:
US $Open
Relocate:
Yes
On
the Market: Looking
Industry: Medical Device
OBJECTIVE
Apply my engineering experience in the production of high quality and
innovative products.
SUMMARY OF QUALIFICATIONS
Over 10 years biomedical
engineering experience-including specialized catheters
Key member on the design
team of an innovative catheter which is patent pending
Computer literate: SolidWorks; Intergraph cad systems; AutoCAD; MS Office,
etc.
ENGINEERING EXPERIENCE
Product Development Engineer (Company), (City), NJ 4/01 to 11/17/01
· Responsible for working with OEM Sales Group for new Product Developments
· Developed quotes for new projects for Labor, Material, Engineering and
Tooling Costs · Worked with customer on Stent Delivery Catheter and Urethra
Catheter · Coordination of Vendors on swagging process for radio opaque
marker bands · Working on Pouch Labels, IFU (Instruction For Use) with
Regulatory Approval · Responsible for training operators with new manufacturing
processes · Familiarity with pebax, carbothane, polycarbonate, and various
bonding methods · Computer Literate with SAP software, EasyLabel. · Responsible
for writing OQ's, PQ's for new products such as Comedicus PerDUCER, Apple
Medical Urethra Catheter and other various OEM projects. · Write IQ's
and Preventive Maintenance SOP and PM check lists.
Project Engineer (Company), (City), PA 9/99 to 4/01 · Responsible for
writing and creating Process Development Studies, Validation Protocols/Studies,
SOP's, SUP's, Quality Plans and Installation, Operational and Performance
Qualification · Set-up Prototype production runs for Validation Studies
and initial production · Implement Quality Plan and Device History Files
for each new product assigned · Coordinate multiple projects for various
customers · Perform Statistical Analysis for processes capabilities
Project Manager, (Company), (City), NC 5/98 - 8/99 · Designed balloon
catheters and prototypes of various bonding techniques · Developed a drainage
catheter juncture hub with locking device, stylet and obturator hub ·
Coordinated and actively participated in: executing project plans; developing
project documentation; defining design output, design control; and creating
design history files · Managed the development of an embryo transfer catheter
for physicians · Generated and implemented standard operating procedures
for FDA regulation, design control and GMP (Good Manufacturing Practices)
compliance · Prepared product instructions, labeling and packaging criteria
for finished product · Established inspection criteria for quality control
on various products · Conducted various audits for ISO-9002 certification
· Fine-tuned proficiency with SolidWorks; Intergraph cad systems and MS
Office · Created process documentation for production
Associate Product Engineer, (Company), (City), PA 1/95 - 4/98
· Promoted and assigned to Project Engineer for Midline Catheters and
PICC products · Conducted product reliability tests to ensure proper function
of design specifications · Documented detailed product/process specifications
· Interacted with other departments to ensure repeat production · Collaborated
with marketing to establish Arrow's latex-free product line · Created
and maintained design control files for CE mark · Investigated and resolved
product problems to correct and improve product quality · Wrote test protocols
and qualification reports
Design Draftsperson 8/90 - 12/94
· Performed four years of CAD solid modeling and prototyping, part detailing,
machine design and drafting support for engineering · Developed and designed
product components and prototypes
EDUCATION
Temple University, PA B.S. Degree in Mechanical Engineering, (in process)
Lehigh Data Processing, Reading, PA Diploma in Computer Programming/Operations,
12/86
Lincoln Technical Institute, Allentown, PA Associate Degree in Architectural
Engineering, 5/83
INQUIRE
Fee based candidate recruiting for
LESS! 
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